FDA Approves Mylan’s Interchangeable Biosimilar Insulin Product

FDA recently approved Mylan’s interchangeable biosimilar insulin product, Semglee, to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. 

Semglee is both biosimilar to and interchangeable with its reference product, Lantus, a long-acting insulin analog. Semglee is the first interchangeable biosimilar product approved in the US for diabetes treatment. 

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce healthcare costs,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement.

“Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Woodcock continued. 

Biological products include medications that treat many serious illnesses and chronic health conditions, including diabetes. 

An interchangeable biosimilar product can be substituted for the reference product without the intervention of the prescriber. Most of the time, the substitution will occur at the pharmacy, called “pharmacy-level substitutions.”

Biosimilar and interchangeable biosimilar products have the potential to reduce healthcare costs. Generally, biosimilars marketed in the US have initial list prices 15 percent to 35 percent lower than comparative list prices of the reference products, an FDA spokesperson explained. 

In September 2020, Mylan and Biocon Biologics launched Semglee in vial and pre-filled pen presentations to help control high blood pressure in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. 

Mylan currently offers the biosimilar at wholesale acquisition cost of $147.98 per package, comprising five 3-millimeter pens. The company also charges $98.65 per one 10-millimeter vial.

These numbers represent the lowest wholesale acquisition cost for any long-acting insulin glargine on the market.

Over 34 million individuals in the US have been diagnosed with diabetes. 

FDA’s approval provides patients with additional safe, high-quality, and potentially cost-effective options for diabetes treatment.

Semglee, offered in 10 milliliter vials and 3 milliliter prefilled pens, is administered once daily. Dosing should be individualized based on the patient’s need and should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine products. 

“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” said Peter Stein, MD, director of the office of new drugs in the FDA’s Center for Drug Evaluation and Research.